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Monday, November 27, 2006

A DRUG company is under criminal investigation for the way it has marketed an unproven “wonder” treatment for multiple sclerosis to thousands of patients.The firm, Daval International, chaired by a discharged bankrupt described by a High Court judge in 2002 as a liar, has been promoting its drug as a “major scientific breakthrough”.

It is being distributed across Britain using a licence granted by a government agency last year despite serious concerns from doctors and multiple sclerosis (MS) experts.

A Sunday Times investigation has found claims that the company misrepresented research to present the drug, Aimspro, in a more positive light.

The Department of Trade and Industry has expressed concern that the company is trading “on future hope” — taking money from vulnerable investors in the expectation that it will become a clinically proven drug.

So far the drug, which is based on a serum from goats injected with inactive HIV virus, has never been properly tested in full clinical trials to assess its safety and efficacy.

However, the Medicines and Healthcare Products Regulatory Agency (MHRA) and government ministers have allowed it to be sold under a “specials” licence which is not designed for the marketing of drugs.

The MHRA was the body that authorised the so-called “elephant man” drugs trial at Northwick Park hospital, which left six healthy young men critically ill.

A key figure lobbying for the drug has been Lord Elder, a friend of Gordon Brown since their schooldays and former adviser to Tony Blair. The peer, who has £300,000 worth of shares in the company and acts as its paid adviser, attended meetings between Daval executives, Brown and other ministers.

This weekend, following The Sunday Times inquiries, the MHRA disclosed that it had been investigating the drug for some time. It is now understood to be looking into the way Aimspro has been sold and marketed to patients in possible breach of the Medicines Act.

The statement said: “The MHRA is conducting a criminal investigation into an unlicensed medicinal product known as Aimspro which is promoted by Daval International Limited.”

Daval has built significant demand for Aimspro among Britain’s 85,000 MS sufferers. Last month, a petition with more than 20,000 signatures was presented to Downing Street calling for NHS backing for the drug.

Daval and its supporters claim that Aimspro “dramatically” alleviates the symptoms of MS, a chronic disease that attacks the central nervous system. Over the past two years a number of stories have appeared in the media claiming patients have regained eyesight and thrown away their walking sticks after taking the drug. During this time, Daval has raised almost £4m from investors on the promise that Aimspro will one day become a clinically proven drug.

David Shotton, Daval’s chairman and main shareholder, was discharged from bankruptcy shortly before he set up the company. The company’s finance director, Graham Ralph, is also a discharged bankrupt.

Shotton, 65, has twice been castigated by High Court judges. In a 1995 case over a disputed bank loan the judge said he was a “wholly unreliable witness” who had a “willingness to advance claims he knew were unjustified”.

Seven years later another judge found that he had lied to attract funding for business schemes. The judge described Shotton as a “most unsatisfactory and untruthful witness . . . well practised in the use of lies and half truths”.Asked to comment on his suitability as chairman of a drugs company, Mr Shotton said last week he had been truthful and “it was unfortunate that the judges preferred the evidence of others”.

In six years the company has commissioned only two proper clinical trials of Aimspro. The first, at St George’s hospital, south London, was aborted half way through after a dispute between the hospital and Daval. The other, at the Radcliffe hospital, Oxford, was too small to establish the drug’s safety.

At the time, Daval was claiming that even severe damage to the optic nerve could be repaired by treatment with Aimspro. But the Oxford trial found no evidence to substantiate this.

Nonetheless, a year later Daval wrote to the government claiming that “clinical, scientific and empirical evidence clearly establishes our clients have a product which will bring substantial relief to thousands of sufferers”. It emphasised that the Oxford trial had been “significant” and “successful”.

A key researcher from the Oxford study said last week the results had been “wholly misrepresented” by Daval. Dr Nikos Evangelou, a consultant neurologist at Queen’s medical centre, Nottingham, is also critical of the lack of research: “It’s inappropriate to promote miraculous patient stories without trial results.” Daval said last week it had never claimed that Aimspro could restore damaged eyesight.

The product has been made available to hundreds of patients through GPs who have been prescribing it on an “informed consent” basis. Daval claims that none of these patients has ever reported an adverse reaction.

But The Sunday Times has spoken to the husband of an MS sufferer in Lincolnshire who sent a 30,000-word complaint to the MHRA about the drug. The husband, who does not wish to be named, claims Daval offered his wife free treatment with Aimspro after he agreed to buy £5,000 worth of its shares.

He claims his wife’s condition deteriorated rapidly after she had been given the drug by Dr Ian Brooman, a GP who was also a director of the company. “Within hours there was a reaction and she started going downhill,” he recalls. “It was as if she had been poisoned.”

His wife’s sight grew worse, she had spasms on her left side and suffered severe pain, according to his statement. But Daval refused to believe that the drug was responsible. Later Dr Brooman returned to take a blood test and retrieved the couple’s supplies of Aimspro.

The husband has passed his documents and tapes to the MHRA. However, last week Dr Brooman, who still administers Aimspro and has shares in Daval, said he was “not aware” of any “reported adverse reaction” from his patients.

The complaint was made in late 2004 and the MHRA is still investigating. Last week Daval said: “Clinicians are currently treating over 200 patients with Aimspro and there have been no reports of adverse reactions.”

The drug has been the subject of an extensive lobbying campaign. In March 2003, Lord Elder attended a meeting at the Treasury in which Shotton and his team met the chancellor for talks. In the meetings, Daval directors described the product and its “remarkable performance”. The purpose of the talks was to obtain government funding for further research and to “fast-track” the drug to approval by the regulator.

Discussions were arranged in 2004 with Lord Warner, the health minister who was then responsible for the MHRA, and Liam Donaldson, the government’s chief medical adviser.

Last November Daval had a breakthrough when the firm it uses to manufacture the drug was given a “specials” licence by the MHRA. “Specials” are intended to certify that a manufacturer can safely make a drug on the request of a doctor as a one-off for a specific patient.

Documents seen by The Sunday Times indicate that Daval was encouraged by health ministers and the MHRA to go down this route. The “specials” licence is now being used by Daval to make widespread sales of the drug, by-passing the higher regulatory standards of a full marketing licence. It promotes the product on its website at £3,000 for a two-month course.A source at the MHRA last week described this as “licensing through the back door”. This raises questions about why the company was apparently encouraged to use the “specials” system.

The decision is all the more remarkable as the DTI’s companies investigation branch has been looking into Daval and its chairman for over two years.

The Sunday Times has seen a letter sent to Daval by a Treasury solicitor on behalf of the department in March 2005 which expresses concern about Daval’s relations with investors suffering from MS who, it says, “may be led to understand that making an investment in Daval shares would give them accelerated and/or privileged access to (Aimspro)”. Daval claims this allegation was unfounded.

Daval, which holds its AGM on Tuesday, said last week it had no knowledge of the MHRA investigation. It added: “Over the last 18 months work has gone into improving Aimspro and ensuring it complies with good manufacturing process. Full clinical trials are imminent.”

Yesterday the MS Society came out publicly against the drug: “We advise people against seeking the treatment until (clinical trial) evidence is published and have become increasingly concerned that the drug continues to be promoted and used without it.”

Professor Gavin Giovannoni, an MS specialist at Barts and the London hospitals, said: “This is a very vulnerable group of desperate patients who have a chronic illness. They’re prepared to try anything, and that’s the tragedy of the situation.”

About Me

Cary J. Polevoy holds M.B.A and undergraduate degrees from Michigan State University. An active investor since 1965, Mr. Polevoy began his investment career as a stockbroker. He has also been a NYSE Supervisory Securities Analyst, director of research, mutual fund portfolio manager, and CEO/CFO of various small companies.
He has worked for Merrill Lynch, EF Hutton, RAC Advisors, Quantum Fund, The Broe Companies, McKinley Medical, among others.
Diagnosed with multiple sclerosis in 1995, he is the author of the book, "MS TOOLKIT - THE PATIENTS' & CAREGIVERS' GUIDE TO MULTIPLE SCLEROSIS."
DISCLAIMER: While I used to be a securities analyst, portfolio manager and registered investment advisor, I no longer am. Any opinions expressed herein are personal opinions and are not expressed as recommendations, advice or bets.